Expressive Writing for Reducing Stress and Diabetic Symptoms in Diabetes Patients

April 13, 2016 updated by: Syracuse University

Expressive Writing: Complementary Treatment for Diabetes

This study will determine whether the psychological benefits of expressive writing extend to diabetic patients, how long the benefits will last, and whether additional expressive writing "booster" sessions will lead to greater and more sustained improvement in diabetes symptoms and well-being.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diabetes is one of the leading causes of blindness, kidney failure, and nontraumatic lower extremity amputation in the United States. Conditions such as stress and depression have been shown to worsen diabetic symptoms. Data indicate that expressive writing (an activity during which individuals deal with stressful experiences by writing about them on paper) has beneficial effects on psychological and physiological outcomes. This study will determine whether diabetes patients can benefit from expressive writing. This study will also determine the duration of the benefits and the effectiveness of booster sessions in improving their diabetic symptoms.

Participants will be randomly assigned to engage in expressive writing or neutral writing for 18 months. Participants in the expressive writing group will write about traumatic or stressful events; participants in the neutral writing group will write about neutral topics that do not affect them emotionally. Some participants in the expressive writing group will receive an additional 4 months of booster sessions of expressive writing. All participants will undergo interviews, blood collection, physical exams and complete clinical scales on their disease status, quality of life, and psychological well-being; these assessments will occur at study entry, every 4 months during the study, and at the end of the study.

Study Type

Interventional

Enrollment (Actual)

187

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Syracuse, New York, United States, 13244
        • Syracuse University
      • Syracuse, New York, United States, 13244
        • State University of New York Medical University
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • Pennsylvania State University
    • Tennessee
      • Nashville, Tennessee, United States, 37235
        • Vanderbilt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of diabetes mellitus made after age 24

Exclusion Criteria:

  • Diabetes-related emergency room visit within 3 months prior to study entry
  • Use of psychiatric medication within 3 months prior to study entry
  • Visual or manual limitations that preclude reading and writing
  • Use of insulin within the first year of diabetes diagnosis
  • Pregnancy or plan to become pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Expressive writing
Behavioral: Expressive writing
Writing as therapeutic intervention
Sham Comparator: Neutral writing
Non-expressive writing
Behavioral: Neutral writing
Non-expressive writing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
hemoglobin A1C (indicator of blood glucose)
Time Frame: baseline, 4 months, 8 months, 12 months, and 16 months
baseline, 4 months, 8 months, 12 months, and 16 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Diabetes symptoms
Time Frame: baseline, 4 months, 8 months, 12 months, and 16 months
baseline, 4 months, 8 months, 12 months, and 16 months
stress levels
Time Frame: baseline, 4 months, 8 months, 12 months, and 16 months
baseline, 4 months, 8 months, 12 months, and 16 months
depression
Time Frame: baseline, 4 months, 8 months, 12 months, and 16 months
baseline, 4 months, 8 months, 12 months, and 16 months
cognitive function
Time Frame: baseline, 4 months, 8 months, 12 months, and 16 months
baseline, 4 months, 8 months, 12 months, and 16 months
quality of life
Time Frame: baseline, 4 months, 8 months, 12 months, and 16 months
baseline, 4 months, 8 months, 12 months, and 16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Syracuse University

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Joshua M. Smyth, PhD, Syracuse University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

October 3, 2005

First Posted (Estimate)

October 5, 2005

Study Record Updates

Last Update Posted (Estimate)

April 15, 2016

Last Update Submitted That Met QC Criteria

April 13, 2016

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AT002477 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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